US regulators on Friday authorised the first COVID-19 shots for children as young as 6 months, paving the way for infant and preschooler vaccinations to begin as soon as next week.
Both the Moderna and Pfizer/BioNTech vaccines are now authorised for emergency use after the US Food and Drug Administration expanded the authorizations
The Food and Drug Administration’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer.
This means US kids under five — roughly 18 million youngsters — are eligible for the shots, about 18 months years after the vaccines first became available in the US for adults, who have been hit the hardest during the pandemic.
Moderna’s vaccine is now authorised for use in children 6 months through 17 years and Pfizer/BioNTech’s for children 6 months through 4 years.
There’s one step left: The Centers for Disease Control and Prevention recommends how to use vaccines and its vaccine advisers are set to discuss the shots Friday and vote on Saturday. A final signoff would come from CDC Director Dr. Rochelle Walensky.
At a Senate hearing Thursday, Walensky said pediatric deaths from COVID-19 have been higher than what is generally seen from the flu each year.
“So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders,” she said.
While young children generally don’t get as sick from COVID-19 as older kids and adults, their hospitalisations surged during the Omicron wave and FDA’s advisers determined that benefits from vaccination outweighed the minimal risks. Studies from Moderna and Pfizer showed side effects, including fever and fatigue, were mostly minor.
“As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalisation and death,” FDA Commissioner Robert Califf said in a statement.
The two vaccine brands use the same technology but there are differences.
Pfizer’s vaccine for kids younger than 5 is one-tenth of the adult dose. Three shots are needed: the first two given three weeks apart and the last at least two months later.
Moderna’s is two shots, each a quarter of its adult dose, given about four weeks apart for kids under 6.
The vaccines are for children as young as 6 months. Moderna next plans to study its shots for babies as young as 3-months-old. Pfizer has not finalised plans for shots in younger infants. A dozen countries, including China, already vaccinate kids under 5.
Dr. Beth Ebel, professor of pediatrics at University of Washington in Seattle, said the tot-sized vaccines would be especially welcomed by US parents with children in daycare where outbreaks can sideline parents from jobs, adding to financial strain.
“A lot of people are going to be happy and a lot of grandparents are going to be happy, too, because we’ve missed those babies who grew up when you weren’t able to see them,” Ebel said.